Chronic Constipation
Conditions
Keywords
Chronic constipation, tegaserod
Brief summary
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male and females of at least 18 years of age * A 12-month history of constipation (defined as \< three spontaneous bowel movements per week and ≥1 of the following symptoms \>25% of the time: hard stools, sensation of incomplete evacuation and straining)
Exclusion criteria
* Patients with cancer, inflammatory bowel disease or other structural bowel disease * Patients who participated in a prior tegaserod study * Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of csbm during 8 weeks of treatment. | — |
| Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation. | — |
| Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain. | — |
| Laxative use. | — |
| Safety and tolerability. | — |
Countries
Switzerland
Outcome results
None listed